IMVIONIX Beovu Acquisition: Ex-Alimera Team Takes Over Novartis Eye Drug
IMVIONIX has acquired US and Canadian rights to Novartis eye drug Beovu. Who the buyers are, Beovu trial data and safety history, and what to watch.
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CVS Split Explained: Aetna and Caremark Stay Together as 9,000 Stores Become CVS Pharmacy
CVS Health will separate into a healthcare solutions company and a standalone CVS Pharmacy by the first half of 2028. Who gets what, the Q3 numbers behind the move and what it means for patients and drugmakers.
Compounding API Warning Letters: FDA Targets Chinese Makers That Refused Records
The FDA has issued warning letters to two Chinese API makers that shipped ingredients for US compounding and refused records requests. What the letters say and why it matters.
GLOBE Model Lawsuit: BIO Joins Fight to Stop Medicare International Drug Pricing
BIO and two California biotech groups have sued to block Medicare’s GLOBE model, which ties Part B drug rebates to prices in 19 countries from 2027.
COMP360 Psilocybin NDA Filed: What Compass Needs for a 2027 Launch
Compass Pathways has completed its COMP360 psilocybin NDA for treatment-resistant depression. Here is the Phase 3 data, the voucher timeline and the DEA hurdle.
Caplyta Bipolar Mania: Second Phase 3 Win Sets Up J&J FDA Filing
J&J’s Caplyta (lumateperone) beat placebo in Study 452, its second pivotal Phase 3 trial in bipolar I mania, clearing the way for an FDA filing. Here is how the two studies compare.
argenx Unnatural Products Acquisition: Inside the $1.15B Bet on Oral Peptides
argenx will buy Unnatural Products for up to $1.15B ($550M upfront) to own an oral macrocyclic peptide platform. Terms, strategy, risks and market context.
Pimjetmi FDA Approval: Third CSF-1R Drug for TGCT Arrives With Once-Daily Dosing
FDA approves Pimjetmi (pimicotinib), a once-daily CSF-1R inhibitor for tenosynovial giant cell tumor, after a 54% vs 3% response in Phase 3 MANEUVER. How it stacks up.
Rybrevant Faspro Wins FDA Nod in Advanced Head and Neck Cancer
FDA grants accelerated approval to subcutaneous amivantamab for recurrent or metastatic HNSCC after a 42% response rate in OrigAMI-4. Eligibility, data, safety and next steps.